Evaluating Safety and Effectiveness of Sequential Hormone and IBI311 Treatments for Adults With Moderate to Severe Active Thyroid Associated Ophthalmopathy

What this Trial Is About

Thyroid-associated ophthalmopathy TAO is an autoimmune disease linked to thyroid problems, commonly seen in adults with Graves disease. TAO can cause complex symptoms affecting vision and daily life, sometimes leading to severe eye damage. This trial evaluates the safety and effectiveness of two treatments, IBI311, a monoclonal antibody targeting the IGF-1 receptor, and sequential hormone therapy, in patients with active moderate to severe TAO who have not been treated with glucocorticoids before. Participants will receive either IBI311 through 8 infusions 10 mgkg initially, then 20 mgkg for the remaining 7 or glucocorticoid therapy with 500 mg methylprednisolone injected intravenously daily for 3 days, followed by infusions every 2 weeks for a total of 8 treatments. The study compares these two treatments head-to-head during the initial treatment phase. During the trial, patients will be monitored up to 24 weeks for treatment responses including changes in clinical activity score, diplopia, proptosis, and overall improvement. Safety will be observed over about one year, tracking any treatment-related side effects. Quality of life and visual field changes will also be assessed. The study spans from screening through treatment and follow-up, with careful safety and efficacy measurements.

The Safety and Efficacy of Sequential Hormone Therapy and IBI311 Therapy in Patients With Active Moderate to Severe TAO in the Initial Treatment.